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The Regulatory Binder

See how the use of a reg binder is considered good clinical practice in research.

Marie Dillard

on 2 November 2015

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Transcript of The Regulatory Binder

The Regulatory Binder


* GCP Guidance

* Binder Contents and Layout

* Study documents and templates
1. Review GCP guidelines and document
2. Review concept of the Regulatory Binder
3. Reg Binder Guidance and Contents
Marie Dillard, MS, CCRC
Clinical Investigation Dept
Naval Medical Center Portsmouth


GCP is an international ethical and scientific quality standard for designing, conducting, collecting,
recording, reporting and maintaining accurate clinical trial data.


Discuss the concept of Good Clinical Practice (GCP) and the guidance for the investigator.
GCP Guidelines in Research
International Conference on Harmonization (ICH)
Tripartite Good Clinical Practice (GCP) Guidelines E6 (R1)
Objective: Provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by regulatory authorities in these jurisdictions.

GCP Guidelines con't

GCP Guidelines con't
GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials involving participation of human subjects.

Compliance of the standards provides public assurance that subject's rights, well-being and safety are protected, and study data is credible. Transparency is key!

Applicable to any clinical investigations that may have an impact on the safety and well-being of human subjects.

GCP represents current thinking of regulatory authorities and considered best practice in research.

Think of the guidelines as standard operating procedures (SOP).
GCP Principles
13 Principles of GCP covers:

1, 2 and 3 covers Ethics
4 and 5 covers Protocol and Science
6, 7, and 8 covers Responsibilities of the IRB, Sponsors, and Investigators
9 covers Informed Consent
10 and 11 covers Data Quality and Integrity
12 covers Investigational Products
13 covers Quality Control and Assurance

Bottom Line:
Safety of study subjects
Credible Data
Investigator Responsibilities ICH GCP Section 4
Investigator's should be qualified to conduct research and agree to comply with regulatory requirements.
Regulatory Binder
The "Super" Investigator Action Figure
Regulatory Binder
Investigator Responsibilities
Regulatory Binder



Regulatory Compliance
Successful Study Management!

Important concepts in a transitional environment

Challenging Situations
Binder Guidance

Establish and set-up binder at the start of a study
Keep it current and up-to-date
File current documents on top
Store in a secure location and accessible to study staff
Do Not
store subject data/PHI in regulatory binders, i.e., signed consent forms, etc.
Customize binder to meet your study needs, i.e., add additional tabs

* Pharmaceutical sponsored studies typically provide regulatory/administrative
binders - follow sponsor guidance *
Common challenging scenarios:
Monitoring Log
IRB Initial Submission and Approval
Protocol/Research Plan
IRB Approved Consent Form
PHI/Consent Waiver (retrospective studies)
CVs/Medical Licenses/CITI Training Certificates
IRBNet User Profile (reminder to obtain IRBnet acct)
Training Log
(reminder to not store data in binder)
Delegation of Duties Log
Safety Reports (AEs, SAEs)
Continuing Review Reports
Final Report

Customize Tabs/Study Specific:
Lab Docs (CLIA, CLIP, normal range values)
Drug/Device Accountability Logs
Data Collection Tools/Source Documents

Binder Contents
"If everyone is moving forward together, then success takes care of itself."

~Henry Ford~
Guideline for good clinical practice E6 (R1).

PI: Smith
Regulatory Binder
Food and Drug Administration (FDA).
Clinical Investigation Dept (CID) sharepoint site
When developing a protocol, the binder...
Reason #1
Keeps things in order:
Research plan
Consent document
IRB application/submissions
IRB communications
Data collection tools
Reason #2
Provides a snapshot
of the study:
When you inherit a study, the binder...
Protocol/Research plan
Study team info
Approved documents
Reports submitted
Records of events
Data collection tools
No searching or guessing
Deployments, PCS, TADs, Leaves and Retirements - Reg binders can be passed on to the next person.
Reason #4
FAQ: If we have the IRBNet program, why do we need to maintain hard copies of the same documents?
Program can crash or become inaccessible
Program changes can occur
Does not contain study specific documents
Delegation of Duties logs
Training logs
Monitoring logs
Enrollment logs
Drug/Device accountability logs
Tracking forms
Miscellaneous documents
Protocol or documents not shared, no access
Regulatory Guidance/Instructions
DoD "Common Rule" 32 CFR 219
DoDI 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
SECNAVINST 3900.39D, DoN Human Research Protection Program (HRPP)
21 CFR 50, Protections of Human Subjects

Definition of Research: Any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Principal Investigator (PI): In DoN-supported human subject research, an individual who possesses the required education, knowledge, skills, experience (credentials) to initiate, conduct and oversee human subject research, and has completed the required research ethics training including human subject protections.
Ensure adequate resources and personnel are available to conduct the research.
Ensure medical care to subject's during and following participation.
Communicate with the IRB before initiating a project and during the course of the project
(e.g., approvals, amendments, adverse events, etc.)

Ensure compliance with protocol by members of the study team.

Ensure proper procedures are followed in obtaining and documenting informed consent process.

Follow proper procedures for safety reporting, i.e., serious adverse events (SAEs).

Ensure accuracy, completeness, legibility and timeliness of records and reports.

Investigator Responsibilities con't
Responsibilities con't
Ensure premature termination or study suspension notifications are made to the IRB, study subjects, sponsors, etc.
Where to go from
Reg Binder Station
Confusion Alley
Why use the Reg Binder?
Reason #3
Full transcript